CAACB Publications
CAACB publications summarize best practices and learnings to mitigate the risk of adventitious agent contamination in biomanufacturing.
2023
- Barone, P.W., Keumurian, F.K, Neufeld, C., Koenigsberg, A., Kiss, R., Leung, J.C., Wiebe, M., Ait-Belkacem, R., Azimpour – Tabrizi, C., Barbiratoe, C., Beurdeley, P., Brussel, A., Cassart, J.P., Cote, C., Deneyer, N., Dheenadhayalan, V., Diaz, L., Geiselhoeringer, A., Gilleece, M.M., Goldmann, J., Hickman, D., Holden, A., Keiner, B., Kopp, M., Kreil, T.R., Lambert, C., Logvinoff, C., Michaels, B., Modrof, J., Mullan, B., Mullberg, J., Murphy, M., O’Donnell, S., Peña, J., Ruffing, M., Ruppach, H., Salehi, N., Shaid, S., Silva, L., Snyder, R., Spedito-Jovial, M., Vandeputte, O., Westrek, B., Yang, B., Yang, P., Springs, S.L.
Historical evaluation of the in vivo adventitious virus test and its potential for replacement with next generation sequencing (NGS)
Biologicals, January 6, 2023
2022
- Koenigsberg, A.L., Fowler, V., Domike, R., Brussel, A., Barone, P.W., Keumurian, F.J., Leung, J.C., Wiebe, M.E., Brewer, M.T., Chan, S., Dumey, N., Fournillier, A., Goodnight, M., Kindermann, J., Leavy, R., Lee, B., Minning, S., Murphy, M., Myers, E., Nahabedian, A., Nanda, K., Parriott, S., Raju, G.K., Scallan, C., Schoch, S., Shiminsky, J., Shum, B., Teitz, S., Westrek, B., Springs, S.L.
MIT CAACB Risk Assessment Case Study: Assessing virus cross-contamination risk between two simultaneous processes in an open biomanufacturing facility.
PDA Journal of Pharmaceutical Science and Technology, October, 2022
2021
- Su, J., Rice, J., Hoffman, J., Alvarado, S., Bailey, M., Kopp, M., Murphy, M., Kiss, R., Barone, P.W., Wiebe, M.E., Springs, S.L., Dehghani, H., Chen, D. Revisiting mouse minute virus inactivation by high temperature short time treatment. Biotechnology & Bioengineering, April 29, 2021
2020
- PW Barone, et. al. The Impact of SARS-CoV-2 on Biomanufacturing Operations. BioPharm International 33 (8) 2020.
- PW Barone, ME Wiebe, JC Leung, et al. Viral contamination in biologic manufacture and implications for emerging therapies. Nat Biotechnol. 38, 563–572 (2020)
2019
- PW Barone, et. al. Biopharmaceutical Industry Approaches to Facility Segregation for Viral Safety: An Effort from the Consortium on Adventitious Agent Contamination in Biomanufacturing. PDA J. Pharm. Sci. Tech. March 2019, 73 (2) 191-203
2018
- PW Barone, FJ Keumurian, J Leung, SL Springs, R Domike, GK Raju, S Monpoeho, K Murray, S Reich, M Ruffing, and M Wiebe. “Quality Risk Management in the Context of Viral Contamination”. In Microbial Control and Identification, edited by Donna Reber (PDA, Washington, 2018)